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The first stem cell therapy for epilepsy enters human testing & Sana's islet cell therapy maintains insulin secretion 14 months after transplant

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Joachim Eeckhout & Eduardo Longoria
March 16, 2026

Good morning! Startups often struggle to succeed, especially in the intense world of Biotech. Highlighting this fact, Pfizer is closing down Ignite, its startup incubation business.

Why it matters: The incubator offered R&D services to a wide variety of startups that worked in fields that could benefit Pfizer; likely an expensive proposition since Ignite only made $41 million last year – down 50% year over year and a rounding error against Pfizer’s $62.5 billion top line. Thankfully for these startups, Pfizer is working to ensure a smooth transition for incubees currently within Ignite but has yet to comment on staff cuts.

Bottom line: Pfizer has decided that helping biotechs is nice, but not that nice.

— Joachim E.

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SNAPSHOT

FDA greenlights the first stem cell–derived therapy for epilepsy to enter human testing

Searching an image for "go for climate action", similar or weather related? Famous Ampelmännchen in green from GDR times.Iconic design from Cold War times.

The U.S. Food and Drug Administration has authorized Shanghai-based Unixell Biotechnology to begin human trials of a donor-derived stem cell therapy designed to treat focal epilepsy by restoring inhibitory brain signaling.

Why it matters: Drug-resistant epilepsy affects millions of patients who continue to experience seizures despite existing medications. A successful cell therapy could offer a new way to treat the disease at its biological source rather than simply suppress symptoms.

Backstory: Current epilepsy treatments largely rely on “small molecule” drugs such as levetiracetam (Keppra), lamotrigine (Lamictal), and carbamazepine (Tegretol). While effective for many patients, these medications can cause significant side effects and fail to control seizures in some cases. Scientists have long explored ways to restore the brain’s natural inhibitory circuits that prevent excessive electrical activity linked to seizures.

Big picture: This milestone also reflects the rapid rise of China’s biotech sector in advanced therapies. Venture capital in the country is increasingly flowing into complex modalities like cell and gene therapy, signaling a shift from earlier “fast-follower” drug development toward innovation.

Zoom in: Unixell’s therapy uses allogeneic stem cells (cells donated from another individual) engineered to produce GABA, the brain’s primary inhibitory neurotransmitter that calms neural activity. In animal studies, the therapy appeared safe and reduced seizures by rebuilding inhibitory neural circuits.

Yes, but: Competition in epilepsy innovation is also intensifying, with Biohaven, Quralis, and Praxis Precision Medicines developing therapies that regulate neuronal activity through potassium or sodium ion channels.

What’s next: The upcoming trial will focus on patients with drug-resistant focal epilepsy, an early-stage test primarily assessing safety. If the early trial shows safety and initial signs of effectiveness, the therapy could advance to larger clinical studies. Success would position Unixell among the first companies pursuing regenerative, cell-based epilepsy treatments.

SNIPPETS

What’s happening in biotech today?

🧬 Insulin implant: And still in the cell therapy field, Sana Biotechnology reported that its investigational donor-derived islet cell therapy, UP421, continued producing insulin in a patient with Type 1 diabetes 14 months after transplantation, with no safety concerns. The therapy uses hypoimmune (HIP)-modified pancreatic islet cells designed to evade immune detection, allowing treatment without immunosuppressive drugs. Data showed sustained C-peptide levels, indicating ongoing insulin production, and responses during mixed meal tolerance tests confirmed insulin secretion after meals. Glycemic control improved between months 12 and 14. Sana now plans to submit an IND application for SC451, a stem cell–derived therapy based on the same technology, and aims to start a Phase 1 trial in 2026, with researchers suggesting the approach could enable a functional cure for Type 1 diabetes.

🌊 Making waves: Owkin has spun out its diagnostics division into a new independent company called Waiv, which raised $33 million in funding led by OTB Ventures and Alpha Intelligence Capital to expand AI-powered precision diagnostics. Waiv will develop artificial intelligence tools that analyze digital pathology images and clinical data to identify biomarkers, predict disease outcomes, and help stratify patients for treatments and clinical trials. The spinout aligns with Owkin’s strategy of building a broader AI-biomedicine ecosystem, leveraging partnerships with hospitals and pharmaceutical companies while creating specialized startups focused on areas such as diagnostics, data, and AI-driven drug discovery.

💸 ADC cash: VALANX Biotech, a Vienna-based startup, has raised €3 million in Series A funding to advance its preclinical antibody-drug conjugate (ADC) candidate VLX-ADC-001, which targets LIV-1 for metastatic triple-negative breast cancer (mTNBC). The funding round included new investors Foundation Fournier-Majoie and FUJIFILM Corporation, alongside existing backers, and will support preclinical development, GMP readiness, and partnership efforts for VALANX’s conjugation platform, which enables precise antibody–drug linking to improve safety and efficacy. The company aims to select a development candidate by June 2026, positioning its technology within the rapidly growing ADC oncology field, where improved control of toxicity, drug-to-antibody ratio, and conjugation sites remains a key challenge.

 🛑 Trial halt: Immutep’s shares plunged up to 88% after the company halted its Phase III TACTI-004 trial of eftilagimod alfa, a soluble LAG-3 protein and MHC Class II agonist, for first-line treatment of advanced non–small-cell lung cancer (NSCLC) due to futility. The study enrolled about 756 patients and tested eftilagimod alfa or placebo alongside Merck’s Keytruda (pembrolizumab) and chemotherapy, with progression-free and overall survival as primary endpoints. The trial was stopped following an interim analysis raising doubts among analysts about the drug’s mechanism of action, despite earlier promising Phase II results. Ending the trial early will extend Immutep’s cash runway to beyond Q2 2027, while the company reviews the data to determine next steps.

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